Phase 3
N=219
An 8-Week Study to Evaluate Tenapanor in the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)
Hyperphosphatemia
Bottom Line
View on ClinicalTrials.gov: NCT02675998 ↗Enrolled (actual)
219
Serious AEs
0.3%
Results posted
Aug 2020
Primary outcome: Primary: Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms — 1.4; 0.6 mg/dL — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tenapanor (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ardelyx
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Placebo Adjusted Change in Serum Phosphate During Randomized Withdrawal Period From Pooled Tenapanor Arms |
1.4; 0.6 | 0.01 sig |
| SECONDARY Change in Serum Phosphate During 8-Week Treatment Period |
-1.1; -1.1; -1.1 | <0.001 sig |
Summary
This phase 3, 8-week, randomized, double-blind, parallel group, multi-center study with a 4-week, placebo-controlled, randomized withdrawal period will evaluate the efficacy, safety and tolerability of Tenapanor to treat hyperphosphatemia in end-stage renal disease patients on hemodialysis (ESRD-HD). Subjects who qualify are randomized into the study will either receive 3 mg BID, 10 mg BID, or a titration regimen of tenapanor.
Eligibility Criteria
Inclusion Criteria
- 18 to 80 years old
- Females must be non-pregnant, non-lactating, and either be post-menopausal for at least 12 months, have documentation of irreversible surgical sterilization, or confirm the use of one of the acceptable contraceptive methods.
- Males must agree to avoid fathering a child and agree to use an appropriate method of contraception
- Chronic maintenance hemodialysis 3x/week for at least 3 months
- Kt/V ≥ 1.3 at most recent measurement prior to screening
- Prescribed and taking at least 3 doses of phosphate binder per day
- Serum phosphate levels should be between 4.0 and 7.0 mg/dL (inclusive) at screening
- For randomization in the study, after 1 week wash-out of phosphate binders, subjects must have serum phosphate level of at least 9 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value
- For randomization in the study, after 2 or 3 weeks wash-out of phosphate binders, subjects must have serum phosphate level of at least 6 mg/dL but below 10 mg/dL and have had an increase of at least 1.5 mg/dL versus pre-wash out value
Exclusion Criteria
- Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at any time point during clinical routine monitoring for the 3 preceding months before screening
- Serum parathyroid hormone >1200 pg/mL
- Persistent metabolic acidosis defined as serum carbon dioxide <18 mmol/L from two consecutive measurements during screening and washout periods
- Clinical signs of hypovolemia at randomization
- History of inflammatory bowel disease (IBD) or diarrhea predominant irritable bowel syndrome (IBS-D)
- Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD or plans to relocate to another center during the study period
- Diarrhea or loose stools during the week before randomization defined as BSFS ≥ 6 and frequency ≥ 3 for 2 or more days
- Any evidence of or treatment of malignancy within one year, excluding non-melanomatous malignancies of the skin
- Positive serology with evidence of significant hepatic impairment or WBC elevation according to the Investigator
- Life expectancy < 6 months
Data sourced from ClinicalTrials.gov (NCT02675998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.